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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Latest Push by CMS for Increased Price Transparency Highlights Opportunities and Risks for Clinical Laboratories, Pathology Groups

As federal regulatory agencies continue to push transparency, hospitals, medical labs, anatomic pathology groups, and other healthcare providers must develop strategies for remaining competitive and maintaining patient volume

More price transparency continues to be a goal of Medicare officials. Some clinical laboratory managers and pathologists may be unaware of a proposed rule issued by the federal Centers for Medicare and Medicaid Services (CMS) in April that would require hospitals to post prices online as early as this January 1, 2019.

This action is a definitive demonstration of how the federal healthcare program continues to scrutinize how healthcare organizations communicate with patients and post their prices. This pressure on healthcare systems and individual providers extends to the clinical laboratories and anatomic pathology groups that support them. Without a plan to address these changes, medical laboratory test volume and practice revenues can be severely impacted.

Recent coverage from RevCycleIntelligence indicates that this trend is only just getting started.

“When you go to receive a healthcare service, there are always going to be situations where you can’t know what the costs will be, especially around emergency situations and some acute situations,” Centers for Medicare and Medicaid (CMS) Administrator Seema Verma told RevCycleIntelligence. “But for a lot of us, we’re going in for planned procedures. You should be able to know what it’s going to cost you.”

In April 2018, CMS posted a proposed rule that requires hospitals to post standard service rates online and update their pricing lists at least annually starting January 1, 2019. While many healthcare organizations currently report pricing to state boards and other online directories, this rule, if enacted, could make it easier for consumers to source reliable pricing information before obtaining care.

“We are concerned that challenges continue to exist for patients due to insufficient price transparency. Such challenges include patients being surprised by out-of-network bills for physicians—such as anesthesiologists and radiologists who provide services at in-network hospitals—and patients being surprised by facility fees and physician fees for emergency room visits. We also are concerned that chargemaster data are not helpful to patients for determining what they are likely to pay for a particular service or hospital stay,” the CMS proposed rule states.

In the proposed rule that references out-of-network bills, pathologists should have been included as a hospital-based physician service—such as anesthesiologists and radiologists—that submits bills to patients for care provided in the hospital. Pathology practice administrators may want to review the specific language of the proposed rule to understand how hospitals served by the pathology group will be required to post prices.

Seema Verma

“If you’re buying a car or pretty much anything else, you’re able to do some research,” Seema Verma (above), Administrator, Centers for Medicare and Medicaid Services told RevCycleIntelligence. “You’re able to know what the quality is. You’re able to make comparisons. Why shouldn’t we be able to do that in healthcare? Every healthcare consumer wants that.” (Photo copyright: Centers for Medicare and Medicaid Services.)

Transparency Concerns Lead to Additional Questions from CMS

Alongside the proposed rule, CMS also is issuing a request for information (RFI) to give healthcare experts an opportunity to:

  1. Demonstrate the impact of current proposals; and,
  2. Make recommendations to further align the proposal with both the needs of healthcare organizations and service providers as well as the cost-reduction goals of CMS.

Key questions, according to RevCycleIntelligence, include:

  • How should “standard charges” be defined (e.g., average or median rates for chargemaster items; average or median rates for groups of services commonly billed together as determined by the hospital; or average discount off the chargemaster amount across all payers)?
  • What types of information would help patients understand hospital prices and patient financial responsibility? How should hospitals use this information to inform patients and decision-making?
  • Should healthcare providers be required to tell patients about their out-of-pocket costs for a service prior to care delivery? Should providers even play a role in informing patients of out-of-pocket costs?
  • Should CMS require providers to give patients information on what Medicare pays for a service?
  • How should CMS enforce healthcare price transparency requirements? Should hospitals have to attest to meeting requirements?

Implications for Healthcare Services and Diagnostics Providers

RevCycleIntelligence reports that between CMS rules and bills introduced by Senators, an increase in healthcare transparency pricing is likely. These requirements will continue to apply pressure to clinical laboratories, anatomic pathology groups, and other diagnostics providers.

Much like the importance of communicating value to the new wave of payer and physician partnerships emerging around the country, transparency will offer an opportunity to communicate value to consumers.

However—particularly for high-margin services and assays—laboratories must create strategies to address pricing transparency and communicate the value of their services if they hope to maintain volumes and financial integrity at existing levels.

A study conducted by Johns Hopkins University researchers and published in The American Surgeon also highlights benefits that transparency might hold outside of simple regulatory compliance.

Analyzing data from six ambulatory care centers from 2016, they found that five out of six reported increases in both patient volume and revenue after adopting price transparency. Half of the centers also reported a reduction in administrative burden—a concern that medical laboratories must also address as streamlining operations and optimizing efficiency becomes a core part of successful lab operation in the face of healthcare reform.

Clinical laboratories and anatomic pathology groups should develop a strategy for addressing new transparency requirements. That strategy should include ways to effectively communicate their value to both healthcare providers and consumers. Should the CMS proposed rule progress to a final rule, failure to address pricing transparency may result in enforcement and compliance concerns—a critical issue for laboratories already facing tighter markets and increased regulatory and payer scrutiny.

—Jon Stone

 

Related Information:

“Just the Beginning” of Healthcare Price Transparency, Verma Says

CMS Aims to Catalyze Advancements in Consumer Price Transparency

Verma: CMS Will “Use Every Lever” for Promoting Interoperability, Data Access

CMS to Require Healthcare Price Transparency Online for Hospitals

Publish Your Prices, Boost Your Bottom Line

Healthcare Price Transparency in U.S. Not Improved in Recent Years

The Impact of Price Transparency for Surgical Services

Patients’ Views on Price Shopping and Price Transparency

CMS Seeks ‘New Direction’ for its Innovation Center as the Agency Evaluates Current Value-Based Payment Models for Medicare Services, including Medical Laboratory Testing

Federal agency receives input on eight focus areas as it looks for ways to enable providers ‘to design and offer new approaches to delivering care’

Medical laboratories and anatomic pathology groups preparing for the transition from fee-for-service healthcare will want to keep a close eye on the Centers for Medicare and Medicaid Services (CMS). The federal agency’s administrator plans to set a “new direction” for CMS as it shifts to value-based reimbursement models for Medicare services that could impact clinical laboratory revenues.

In an informal Request for Information (RFI), the Center for Medicare and Medicaid Innovation (CMMI) sought feedback on a “new direction to promote patient-centered care and test market-driven reforms that empower beneficiaries as consumers, provide price transparency, increase choices and competition to drive quality, reduce costs, and improve outcomes.”

CMS to ‘Move Away’ from Engineering Healthcare ‘From Afar’

The agency requested input on eight focus areas:

1. Increased participation in Advanced Alternative Payment Models (APMs);

2. Consumer-directed care and market-based innovation models;

3. Physician specialty models;

4. Prescription drug models;

5. Medicare Advantage innovation models;

6. State-based and local innovation;

7. Mental and behavioral health models; and,

8. Program integrity.

Comments from healthcare providers, clinicians, states, payers, and stakeholders were accepted through November 20, 2017.

In a Wall Street Journal (WSJ) op-ed, CMS Administrator Seema Verma explained the agency’s process moving forward. “We will move away from the assumption that Washington can engineer a more efficient healthcare system from afar—that we should specify the processes healthcare providers are required to follow,” she wrote.

CMS Administrator Seema Verma (above) plans to lead the Center for Medicare and Medicaid Innovation “in a new direction” and may be signaling a willingness to give providers more flexibility with value-based care payment models for Medicare services. (Photo copyright: Healthcare Dive.)

The RFI states the new model design will follow six guiding principles:

1. Choice and competition in the market;

2. Provider choice and incentives;

3. Patient-centered care;

4. Benefit design and price transparency;

5. Transparent model design and evaluation; and,

6. Small scale testing.

Providers Need Freedom to Design New Approaches to Healthcare

Verma said CMS plans to review all Innovation Center models to determine “what is working and should continue, and what isn’t and shouldn’t.” She voiced concern that the complexity of some of the current models may have encouraged consolidation in the healthcare system, resulting in fewer choices for patients.

“We must shift away from a fee-for-service system that reimburses only on volume and move toward a system that holds providers accountable for outcomes and allows them to innovate,” Verma wrote in the WSJ op-ed. “Providers need the freedom to design and offer new approaches to delivering care. Our goal is to increase flexibility by providing more waivers from current requirements.”

Actual Progress of Value-based Healthcare ‘Herky-Jerky’

In its reporting on the recent CMS announcements, Healthcare DIVE suggested that the U.S. Department of Health and Human Services (HHS) “is looking to make some potentially major changes” in value-based payment models.

However, Neil Smiley, CEO of Loopback Analytics, which assists healthcare organizations with managing outcome-based care, believes the transition to value-based care may face stiffer headwinds under the new administration. He points to an August CMS proposal that canceled some mandatory bundled payment programs and scaled back others as an indication that healthcare transformation could be slowing.

“The pace at which CMS committed to rolling out value-based care is fundamentally different from the pace we’re currently seeing,” he told Health IT. “The progress toward value-based care, instead of this steady momentum they expected, is more of a herky-jerky fashion.”

Modify, Don’t Abandon Existing Payment Models, suggests HCTTF

The Health Care Transformation Task Force (HCTTF), a 42-member industry consortium, was among the stakeholders who responded to CMS’ RFI. In a 22-page letter, the task force reiterated its support for the healthcare system’s transformation to value-based payment and care delivery, while outlining areas for improvements. The group urged CMS to continue to develop new models while modifying, rather than abandoning, existing models that show promise and need time to achieve a lasting return.

“We would like CMS to continue support for promising models while balancing the current portfolio with new, innovative payment models,” Clare Wrobel, Director of Payment Reform Models at HCTTF, told Home Health Care News. “[But] it would be a mistake to discard current models that providers have already invested in and are showing real promise.”

Smiley, meanwhile, suggests clinical laboratory managers, pathologists, and other healthcare providers keep watch as healthcare transformation continues to evolve.

“The fee-for-service model, love it or hate it, is not dying. The organism has adapted,” he told Health IT. “For those that were aggressive early adopters of value-based care and really believed what they were hearing, and have gone fully after value-based care, some of them may feel a little exposed. If they go too hard too fast, they may suffer economically if they misjudge the pace at which this moves.”

—Andrea Downing Peck

Related Information:

Centers for Medicare and Medicaid Services: Innovation Center New Direction

Medicare and Medicaid Need Innovation

CMS Seeks ‘New Direction’ for Innovation Center

Comprehensive Care for Joint Replacement Payment Model

Task Force Calls on CMS to Encourage Alternative Payment Models

CMS Request for Information: Innovation Center New Direction

Task Force Urges CMS to Preserve Value Based Payment Models

CMS Missed 96 Hospitals with Suspected HAI Reporting Due to Limited Use of Analytics, OIG Report Reveals

OIG suggests better use of analytics by CMS could prevent gaming of the system by providers; clinical laboratories can help through test utilization management technology

It may come as a surprise to many hospital-based pathologists and clinical laboratory managers that the Centers for Medicare and Medicaid Services (CMS) has reason to suspect that some hospitals are “gaming” the system in how they report hospital-acquired infections (HAIs).

In 2015, CMS implemented the Hospital-Acquired Condition Reduction Program (HACRP) as part of the Patient Protection and Affordable Care Act (ACA). The HACRP program incentivizes hospitals to lower their HAI rates by adjusting reimbursements according to the inpatient quality reporting (hospital IQR) data provided by the healthcare providers. Hospital IQR data is the basis on which CMS validates a hospital’s HAI rate (among other things CMS is tracking) to determine the hospital’s reimbursement rate for that year.

However, an April 2017 report by the Office of the Inspector General US Department of Health and Human Services (OIG) noted that CMS was not doing enough to identify and target hospitals with abnormal reporting of HAIs.

The OIG reported:

  • CMS, in 2016, met its regulatory requirement to validate inpatient quality reporting data;
  • It reviewed data of 400 randomly selected hospitals as well as 49 hospitals targeted for failing to report half their HAIs, or for low scores in the prior year’s validation process;

However, OIG also reported that CMS did not include hospitals that displayed abnormal data patterns in its targeted sample. Targeting those hospitals, according to the OIG, could identify inaccurate reporting.

CMS staff had identified 96 hospitals with aberrant data patterns, but did not target them for validation—even though the agency can select up to 200 targeted hospitals for review, Becker’s Hospital Review pointed out.

Dollars More Important than Deaths

According to the OIG report, Medicare excluded in its investigation dozens of hospitals with suspected HAI reporting. This is odd since the CMS and the Centers for Disease Control (CDC) apparently are aware that some healthcare providers have manipulated data to improve their quality measure scores and thus increase their reimbursement rates.

“Collecting and analyzing quality data is increasingly central to Medicare programs that link payments to quality and value. Therefore, it is important for CMS to ensure that hospitals are not gaming [manipulating data to improve scores] their reporting of quality data,” the OIG report noted.

“There are greater requirements for what a company says about a washing machine’s performance than there is for a hospital on quality of care. And this needs to change,” stated Peter Pronovost, MD, PhD, in the Kaiser Health News article. “We require auditing of financial data, but we don’t require auditing of healthcare quality data, and that implies that dollars are more important than deaths.” Pronovost is Senior Vice President for Patient Safety and Quality at Johns Hopkins University School of Medicine.

 

Peter Pronovost, MD, PhD

Peter Pronovost, MD, PhD (above) testifying on preventable deaths before the Senate Subcommittee on Primary Health and Aging in 2014. He is Senior Vice President for Patient Safety and Quality at Johns Hopkins University School of Medicine in Baltimore. Pronovost told Kaiser Health News that there are no uniform standards for reviewing data that hospitals report to Medicare. (Photo copyright: US Senate Committee on Health, Education, Labor and Pensions.)

Medicare Missed Hospitals with Suspected HAI Data

CMS should have done an in-depth review of many hospitals that submitted “aberrant data patterns” in 2013 and 2014, the OIG stated in its report. According to a Kaiser Health News article, such patterns could include:

  • A rapid change in results;
  • Improbably low infection rates; and
  • Assertions that infections nearly always struck before patients arrived at the hospital.

“There’s a certain amount of blind faith that hospitals are going to tell the truth. It’s a bit much to expect that if they had a bad record they are going to fess up to it,” noted Lisa McGiffert, Director of the Safe Patient Project at Consumers Union, in the Kaiser Health News article.

CMS Needs Better Data Analytics

So, what does the OIG advise CMS to do? The agency called for “better use of analytics to ensure the integrity of hospital-reported quality data.” Specifically, OIG suggested CMS:

  • Identify hospitals with abnormal percentages of patients who had infections on admission;
  • Apply risk scores to identify hospitals with high propensity to manipulate reporting;
  • Use experiences to create and improve models that identify hospitals most likely to game their reporting.

CMS’ Administrator Seema Verma reportedly responded, “We will continue to evaluate the use of better analytics as feasible, based on Medicare’s operational capabilities.”

Medical Laboratory Diagnostic Testing Part of Gaming the System

A 2015 CMS/CDC joint statement noted “three ways that hospitals may be deviating from CDC’s definitions for reportable HAIs,” and two involve diagnostic test ordering. According to the OIG report, they include:

  • Overculturing: Diagnostic tests may be overutilized by providers in absence of clinical symptoms. Hospitals may use positive results to game their data by claiming infections that appeared days later were present on admission and thus not reportable.
  • Underculturing: Hospitals underculture when they do not order diagnostic tests in the presence of clinical symptoms. By not ordering the test, the hospital does not learn whether the patient truly has an infection and, therefore, the hospital does not have to report it.
  • Adjudication: Hospital administrative staff may inappropriately overrule those who report infections. HAIs are, therefore, not shared.

Clinical Laboratories Can Help

One in 25 people each day receives an HAI, CDC estimates. The OIG findings should be a reminder to medical laboratories and pathology groups that quality measures and patient outcomes are often transparent to media, patients, and the public.

One way medical laboratories in hospitals and health systems can help is by investing in utilization management technology and protocols that ensure appropriate lab test utilization. Informing doctors on the availability of appropriate diagnostic tests based on patients’ existing conditions, unique physiologies, or medical histories, could help prevent hospitals from inadvertently or deliberately game the system.

Clearly, transparency in healthcare is increasing. That means there will be more news stories revealing federal agencies’ failures to respond to healthcare data in ways that could have protected patients and the public. Clinical laboratories don’t want to be included in negative reporting.

—Donna Marie Pocius

Related Content:

CMS Validated Hospital Inpatient Quality Reporting Program Data, But Should Use Additional Tools to Identify Gaming

Medicare Failed to Investigate Suspicious Infection Cases from 96 Hospitals

CMS Can Do More to Validate Hospital-Reported Infection Data, OIG Report Finds

Study Suggests Medical Errors Now Third Leading Cause of Death in the US

Research Study at Johns Hopkins University Reveals CDC Does Not Record Medical Errors in Annual Mortality Report, Yet Such Errors Are Third Leading Cause of Death

Biggest Opportunity for Clinical Laboratory Industry is Utilization Management of Lab Tests, But Only If It Is Done Well

Lessons from the Pioneers: Reporting Healthcare-Associated Infections

Webinar: Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value 

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